Mitigating Contamination Challenges in Cell Based Regenerative Therapies

University of Maryland BioPark
801 West Baltimore Street, Baltimore, MD, 21201 

Cell therapy and regenerative medicine technologies require strict cell manufacturing procedures to be defined and addressed. Maintenance of the aseptic environment is critical to preclude extrinsic contamination risks, similar to conventional pharmaceutical manufacturing. Intrinsic contamination risks exist in all cell manufacturing processes owing to the use of cells as the raw materials, which cannot be sterilized, thus giving rise to primary and secondary risks of cell contamination and cross-contamination, respectively. 

The goal of contamination control in cell-based product manufacturing should be to map out the whole process and understand the risks for each step in the manufacturing operation. A comprehensive view of all of these elements, and anywhere there’s an opportunity to mitigate contamination risk, including automation, is critical. Potential detrimental effects on the microbiological safety of any cell based products should be considered as high priority.A proactive contamination control mindset is critical. 

This one day fast track intensive workshop will cover contamination issues from facility design to product release and how to develop a contamination control strategy. This will address, ATMP Guidance, EU Annex 1, EU Annex 2, FDA’s Aseptic Guidance and more. 

Which industries does this workshop apply to? 

Cell Therapy, Gene Therapy, Tissue Banks and Wound Care products using live cells 

Who will benefit? 

Quality, Manufacturing, Research and Development, Facilities, Microbiology and Operators 

Hands On Fungal Identification

An Intensive & Interactive 3 Day Laboratory Workshop

Innovation Stockyard At the Kit Bond Incubator
4221 Mitchell Avenue, St. Joseph, MO 64507 

Learn Fungal Identification the correct way by understanding classification and exploring macroscopic as well as microscopic features which differentiate each genus and species. Using simple identification keys developed by Microrite, learn to identify important cleanroom isolates. 

This hands-on workshop will allow you to examine up to 30 commonly encountered cleanroom fungi. You will also learn about the various phases of the same fungus often not caught in automated microbial identification reports. 

Since fungi isolated from cleanrooms may originate from various sources it is important to identify these fungi to pinpoint the contamination sources. You can use the knowledge gained in this hands-on workshop to evaluate the condition of your clean facility and identify risk to your product. 

Attendees will learn how to reduce the number of incorrect IDs by understanding the polyphasic approach to fungal identification. Additionally, examining morphology and the structures of cleanroom fungal isolates helps in understanding the efficacy of disinfectants against hard to kill fungi. 

Which industries does this workshop apply to? 

Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics, Food, Beverage, and Pharmacies 

Who will benefit? 

Quality Assurance, QC Microbiologists, and Training Personnel 

Particulate and Microbial Investigations Workshop

University of Maryland BioPark
801 West Baltimore Street, Baltimore, MD 21201 

Microbial and particulate contamination has many consequences; patient harm, failed media fills, inconclusive investigations and continuing contamination events are frequently associated with voluntary or involuntary plant shutdowns, product recalls, and warning letters. 

This comprehensive two day course on investigation of microbial and particulate contamination in cleanrooms, manufacturing processes, laboratory testing, and product will provide the tools for conducting in-depth fact based and scientifically sound investigations. Investigations are costly and labor intensive; detection of microbial and particulate contamination requires prompt attention and a good understanding of contaminants. 

Which industries does this seminar apply to? 

Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics and Cleanroom Equipment Suppliers 

Who will benefit? 

Quality Assurance, Quality Control, Microbiologists, Validation, Facilities, Manufacturing and Engineering 

Particulate and Microbial Investigations Workshop

Courtyard by Marriott
777 Memorial Drive, Cambridge, MA, 02139 

Microbial and particulate contamination has many consequences; patient harm, failed media fills, inconclusive investigations and continuing contamination events are frequently associated with voluntary or involuntary plant shutdowns, product recalls, and warning letters. 

This comprehensive two day course on investigation of microbial and particulate contamination in cleanrooms, manufacturing processes, laboratory testing, and product will provide the tools for conducting in-depth fact based and scientifically sound investigations. Investigations are costly and labor intensive; detection of microbial and particulate contamination requires prompt attention and a good understanding of contaminants. 

Which industries does this seminar apply to? 

Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics and Cleanroom Equipment Suppliers 

Who will benefit? 

Quality Assurance, Quality Control, Microbiologists, Validation, Facilities, Manufacturing and Engineering